TABLE 2.
Secondary Efficacy Endpoints (Full Analysis Set)
| Low-dependence Stratum (2 mg) | High-dependence Stratum (4 mg) | |||
| Parameter | NRT (n = 241) | Placebo (n = 242) | NRT (n = 120) | Placebo (n = 119) |
| Continuous successful smoking cessation* | ||||
| Week 12 | ||||
| Failed, n (%) | 198 (82.2) | 201 (83.1) | 93 (77.5) | 106 (89.1) |
| Succeeded, n (%) | 43 (17.8) | 41 (16.9) | 27 (22.5) | 13 (10.9) |
| P value† | 0.740 | 0.016 | ||
| OR† | 1.09 | 2.46 | ||
| 95% CI | 0.66–1.78 | 1.18–5.10 | ||
| Week 24 | ||||
| Failed, n (%) | 210 (87.1) | 210 (86.8) | 97 (80.8) | 107 (89.9) |
| Succeeded, n (%) | 31 (12.9) | 32 (13.2) | 23 (19.2) | 12 (10.1) |
| P value† | 0.951 | 0.046 | ||
| OR† | 0.98 | 2.18 | ||
| 95% CI | 0.56–1.72 | 1.02–4.67 | ||
| Month 12 | ||||
| Failed, n (%) | 215 (89.2) | 214 (88.4) | 101 (84.2) | 108 (90.8) |
| Succeeded, n (%) | 26 (10.8) | 28 (11.6) | 19 (15.8) | 11 (9.2) |
| P value† | 0.822 | 0.123 | ||
| OR† | 0.93 | 1.85 | ||
| 95% CI | 0.51–1.69 | 0.84–4.07 | ||
| Long-term successful smoking cessation rates at week 24† | ||||
| Failed, n (%) | 195 (80.9) | 199 (82.2) | 91 (75.8) | 100 (84.0) |
| Succeeded, n (%) | 46 (19.1) | 43 (17.8) | 29 (24.2) | 19 (16.0) |
| P value† | 0.648 | 0.111 | ||
| OR† | 1.12 | 1.72 | ||
| 95% CI | 0.69–1.82 | 0.89–3.32 | ||
| 7-Day point prevalence abstinence (%) | ||||
| Week 1 | 12.5 | 12.0 | 20.0§ | 10.1 |
| Week 2 | 21.2 | 23.1 | 33.3 | 26.1 |
| Week 4 | 32.0 | 26.3 | 36.7 | 30.3 |
| Week 6 | 35.7 | 37.2 | 41.7 | 32.8 |
| Week 12 | 41.5 | 39.3 | 40.8§ | 26.1 |
| Week 24 | 41.5 | 43.1 | 50.0 | 43.7 |
| Relief of craving/withdrawal symptoms, total scores (successful quitters) | ||||
| Week 1 | 7.42 | 6.14 | 5.89 | 9.20 |
| Week 2 | 6.42 | 4.67 | 5.07 | 8.02 |
| Week 4 | 4.52 | 4.18 | 3.01 | 7.33 |
| Week 6 | 4.09 | 3.71 | 3.13 | 6.56 |
| Change from baseline in body weight (successful quitters), kg (SD) | ||||
| Week 6 | 1.5 (1.76) | 1.3 (2.45) | 1.7 (2.93) | 1.5 (1.76) |
| Week 12 | 1.9 (2.24) | 1.8 (2.43) | 1.8 (2.94) | 1.8 (2.22) |
| Week 24 | 2.0 (2.75)§ | 1.2 (2.56) | 2.4 (4.05) | 2.8 (2.80) |
*Proportion of subjects who achieved the primary endpoint at week 6 and quit smoking completely by week 12 and week 24.
†P value based on Cochran-Mantel-Haenszel test (adjusted by center); OR based on logistic model (adjusted by center).
‡Proportion of subjects who achieved the primary endpoint with no more than 6 cumulative days of smoking from week 6 to week 24.
§P < 0.05.
CI, confidence interval; NRT, nicotine replacement therapy; OR, odds ratio.